The Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program: protocol for a two-arm parallel partially nested randomized controlled feasibility trial with progression to full-scale trial

Trials

Shadi Gholizadeh¹  Brooke Levis²  Alexander W. Levis³  Linda Kwakkenbos⁴  Maria E. Suarez-Almazor⁵  Maggie Larche⁶  Maureen D. Mayes⁷  Tracy Frech⁸  Jessica Gordon⁹  Susan J. Bartlett^1,10  Andrea Benedetti^1,11  Lorinda Chung^1,12  Janet Pope^1,13  Lisa R. Jewett^1,14  Vanessa L. Malcarne^1,15  Ward van Breda^1,16  Dan Bilsker^1,17  Nicole Culos-Reed^1,18  Tatiana Sofía Rodríguez-Reyna^1,19  Kimberly A. Turner^2,20  Julia Nordlund^2,20  Marie-Eve Carrier^2,20  Claire Fedoruk^2,20  Lydia Tao^2,20  Julie Cumin^2,20  Marie Hudson^2,21  Richard S. Henry^2,22  Brett D. Thombs^2,23  Joep Welling^2,24  Catherine Fortuné^2,25  Pamela Piotrowski^2,26  Amanda Wurz^2,27  Karen Gottesman^2,28  Laura Dyas^2,29  Karen Nielsen^3,30  Maureen Sauve^3,31  Luc Mouthon^3,32  Warren R. Nielson^3,33  Sindhu R. Johnson^3,34  Catarina Leite^3,35  Isabelle Boutron^3,36 

[1] California School of Professional Psychology/Alliant, Los Angeles, CA, USA;Centre for Prognosis Research, School of Medicine, Keele University, Keele, Staffordshire, UK;Department of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, MA, USA;Department of Clinical Psychology, Radboud University, Nijmegen, The Netherlands;Department of Medical Psychology, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands;Department of General Internal Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA;Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada;Department of Internal Medicine, University of Texas McGovern School of Medicine, Houston, TX, USA;Department of Internal Medicine, University of Utah, Salt Lake City, UT, USA;Department of Medicine, Hospital for Special Surgery, New York City, NY, USA;Department of Medicine, McGill University, Montreal, Quebec, Canada;Centre for Outcomes Research and Evaluation, Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada;Department of Medicine, McGill University, Montreal, Quebec, Canada;Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada;Respiratory Epidemiology and Clinical Research Unit, McGill University Health Centre, Montreal, Quebec, Canada;Department of Medicine, Stanford University, Palo Alto, CA, USA;Department of Medicine, Palo Alto VA Health Care System, Palo Alto, CA, USA;Department of Medicine, University of Western Ontario, London, Ontario, Canada;Department of Psychology, Jewish General Hospital, Montreal, Quebec, Canada;Department of Psychology, San Diego State University, San Diego, CA, USA;Joint Doctoral Program in Clinical Psychology, San Diego State University/University of California San Diego, San Diego, CA, USA;Faculty of Behavioural and Movement Sciences, VU University, Amsterdam, The Netherlands;Faculty of Health Sciences, Simon Fraser University, Burnaby, British Columbia, Canada;Department of Psychiatry, University of British Columbia, Vancouver, British Columbia, Canada;Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada;Department of Oncology, Cumming School of Medicine, Calgary, Canada;Department of Psychosocial Resources, Tom Baker Cancer Centre, Alberta Health Services, Calgary, Alberta, Canada;Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico;Lady Davis Institute of the Jewish General Hospital, 3755 Côte-Sainte-Catherine Road, Montreal, H3T 1E2, Quebec, Canada;Lady Davis Institute of the Jewish General Hospital, 3755 Côte-Sainte-Catherine Road, Montreal, H3T 1E2, Quebec, Canada;Department of Medicine, McGill University, Montreal, Quebec, Canada;Lady Davis Institute of the Jewish General Hospital, 3755 Côte-Sainte-Catherine Road, Montreal, H3T 1E2, Quebec, Canada;Department of Psychiatry, McGill University, Montreal, Quebec, Canada;Lady Davis Institute of the Jewish General Hospital, 3755 Côte-Sainte-Catherine Road, Montreal, H3T 1E2, Quebec, Canada;Department of Psychiatry, McGill University, Montreal, Quebec, Canada;Department of Medicine, McGill University, Montreal, Quebec, Canada;Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada;Respiratory Epidemiology and Clinical Research Unit, McGill University Health Centre, Montreal, Quebec, Canada;Department of Psychology, McGill University, Montreal, Quebec, Canada;Department of Educational and Counselling Psychology, McGill University, Montreal, Quebec, Canada;Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada;NVLE Dutch patient organization for systemic autoimmune diseases, Utrecht, The Netherlands;Ottawa Scleroderma Support Group, Ottawa, Ontario, Canada;Private practice – Nutrition, Milton, Ontario, Canada;School of Kinesiology, University of the Fraser Valley, Chilliwack, British Columbia, Canada;Scleroderma Foundation, Los Angeles, CA, USA;Scleroderma Foundation, Michigan Chapter, Southfield, MI, USA;Scleroderma Society of Ontario, Hamilton, Ontario, Canada;Scleroderma Society of Ontario, Hamilton, Ontario, Canada;Scleroderma Canada, Hamilton, Ontario, Canada;Service de Médecine Interne, Centre de Référence Maladies Autoimmunes Systémiques Rares d’Ile de France, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France;APHP-CUP, Hôpital Cochin, Université de Paris, F-75014, Paris, France;St. Joseph’s Health Care, London, Ontario, Canada;Toronto Scleroderma Program, Mount Sinai Hospital & Toronto Western Hospital, Toronto, Ontario, Canada;Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Ontario, Canada;University of Minho, Braga, Portugal;Université de Paris, Centre of Research Epidemiology and Statistics (CRESS), Inserm, INRA, Paris, France;Centre d’Épidémiologie Clinique, Assistance Publique–Hôpitaux de Paris (AP-HP), Hôpital Hôtel Dieu, Paris, France;

关键词: Scleroderma;    Systemic sclerosis;    Self-management;    Self-efficacy;    Patient activation;    Randomized controlled trial;    e-Health;   

DOI  :  10.1186/s13063-021-05827-z

来源: Springer

【 摘 要 】

BackgroundSystemic sclerosis (scleroderma; SSc) is a rare autoimmune connective tissue disease. We completed an initial feasibility trial of an online self-administered version of the Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program using the cohort multiple randomized controlled trial (RCT) design. Due to low intervention offer uptake, we will conduct a new feasibility trial with progression to full-scale trial, using a two-arm parallel, partially nested RCT design. The SPIN-SELF Program has also been revised to include facilitator-led videoconference group sessions in addition to online material. We will test the group-based intervention delivery format, then evaluate the effect of the SPIN-SELF Program on disease management self-efficacy (primary) and patient activation, social appearance anxiety, and functional health outcomes (secondary).MethodsThis study is a feasibility trial with progression to full-scale RCT, pending meeting pre-defined criteria, of the SPIN-SELF Program. Participants will be recruited from the ongoing SPIN Cohort (http://www.spinsclero.com/en/cohort) and via social media and partner patient organizations. Eligible participants must have SSc and low to moderate disease management self-efficacy (Self-Efficacy for Managing Chronic Disease (SEMCD) Scale score ≤ 7.0). Participants will be randomized (1:1 allocation) to the group-based SPIN-SELF Program or usual care for 3 months. The primary outcome in the full-scale trial will be disease management self-efficacy based on SEMCD Scale scores at 3 months post-randomization. Secondary outcomes include SEMCD scores 6 months post-randomization plus patient activation, social appearance anxiety, and functional health outcomes at 3 and 6 months post-randomization. We will include 40 participants to assess feasibility. At the end of the feasibility portion, stoppage criteria will be used to determine if the trial procedures or SPIN-SELF Program need important modifications, thereby requiring a re-set for the full-scale trial. Otherwise, the full-scale RCT will proceed, and outcome data from the feasibility portion will be utilized in the full-scale trial. In the full-scale RCT, 524 participants will be recruited.DiscussionThe SPIN-SELF Program may improve disease management self-efficacy, patient activation, social appearance anxiety, and functional health outcomes in people with SSc. SPIN works with partner patient organizations around the world to disseminate its programs free-of-charge.Trial registrationClinicalTrials.govNCT04246528. Registered on 27 January 2020

【 授权许可】

CC BY